(40 days)
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious isolates. This 510(k) is for Delafloxacin the dilution range of 0.0005-8 ug/ml for testing non-fastidious gram positive organisms on the Sensititre 18 - 24 hour MIC panel. The approved primary "Indications for Use" and clinical significance for non-fastidious Gram positive isolates: Staphylococcus aureus (including MRSA and MSSA) Staphylococcus haemolyticus Staphylococcus lugdunensis Enterococcus faecalis
Not Found
The provided document is a 510(k) clearance letter from the FDA for an antimicrobial susceptibility testing system. It includes information about the device, its indications for use, and regulatory details. However, it does not contain detailed information regarding the acceptance criteria, specific performance study results, sample sizes for test and training sets, expert qualifications, or adjudication methods for establishing ground truth.
Therefore, I cannot extract the requested information from the provided text. The document serves as a regulatory clearance, not a technical report or scientific publication detailing the device's validation studies.
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).